Eludril Spray
6. Further Information
What Eludril contains
The active substances are chlorhexidine digluconate (0.05 %) and tetracaine hydrochloride (0.015 %).
The other ingredients are ethyl alcohol 95%, polyethylene glycol 300, saccharin sodium, aromatic compound, phosphoric acid, purified water, nitrogen (propellant gas).
What Eludril looks like and contents of the pack
Eludril spray is available as a 75ml white plastic coated glass bottle containing 55 ml of solution.
Marketing Authorisation Holder Pierre Fabre Limited
Hyde Abbey House - 23 Hyde Street - Winchester Hampshire S023 7DR United Kingdom
Manufacturer
Pierre Fabre Medicament Production
45, place Abel Gance - 92100 Boulogne - France
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name Reference Number
Eludril spray: PL 00603/0013R
This is a sendee provided by the Royal National Institute of the Blind.
This leaflet was last approved in {MM/YYYY}
Pierre Fabre
*XXXXXX»NotELUDRil__spray_UK.indd 1
Updated in UKaffilate office: 16/06/2010: 14:55:00
Eludril™
spray
(Chlorhexidine digluconate 0.05%) (Tetracaine hydrochloride 0.015%)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Eludril carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms persist or worsen.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Eludril is and what it is used for
2. Before you use Eludril
3. How to use Eludril
4. Possible side effects
5. How to store Eludril
6. Further information
1. What Eludril is and what it is used for
Eludril spray is an antibacterial and anaesthetic spray.
Eludril spray is used to treat and help prevent:
- Gum or the lining of the mouth inflammations, common mouth ulcers and minor infections in the mouth.
- Tonsillitis, pharyngitis and minor infections of the throat.
It can also be used as an add-on treatment in very severe gingivitis [Vincent’s angina], in oral fungus disease, after operative or dental procedures in the mouth or throat and for general oral hygiene.
2. Before you use Eludril
Do not use Eludril:
• If you are allergic (hypersensitive) to chlorhexidine, tetracaine, or any of the other ingredients of Eludril.
• For children under 12 years of age.
• At the same time as toothpastes.
I
Take special care with Eludril
One of the active ingredients of Eludril (chlorhexidine) is incompatible with some toothpastes, therefore the spray should only be used a short time after usual toothbrushing and thorough rinsing of the mouth. .Alternatively, use the spray at a different time of day to when you brush your teeth.
Eludril spray should not be used immediately before eating as tetracaine is a mild anaesthetic and could induce choking.
As this medicine contains an anaesthetic it must not come into contact with the eyes, or be placed in the nose or ears.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and Breastfeeding
If you think you might be pregnant, planning to get pregnant or are breastfeeding, you should not use Eludril unless your doctor advises.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed with Eludril.
Important information about some of the ingredients of Eludril
This medicine contains alcohol. As this medicine is a spray and is not swallowed there should be no side effect. However, if accidentally swallowed by a child seek immediate medical help.
3. How to use Eludril
.Always use Eludril exactly as you doctor has told you. Do not exceed the stated dose. You should check with your doctor or pharmacist if you are not sure.
Shake the bottle before use.
Place the nozzle inside the mouth in the direction of the affected area of the mouth and spray. Gently activate the spray for two or three seconds.
Spray can be used three to four times a day but not immediately before meals.
Eludril is not suitable for children under the age of 12 years.
If there is evidence of irritation or aggravation of your symptoms, a doctor or dentist should be consulted.
If you use more Eludril than you should
If you or a child accidentally takes too much medicine:
- a small amount should have no side effect
- a large amount (for example a whole bottle) you should immediately contact your doctor or go to the nearest hospital emergency department. The tetracaine will have the effect of tongue numbness and a possible choking sensation. Side effects with chlorhexidine are unlikely but you might have symptoms of digestive discomfort, burning sensation in your mouth and throat, or slight incoordination of your movements.
.Always take the labelled medicine package with you, whether there is any medicine left or not.
W™'»e®ded: ?6/06/2010: 14:55:00
If you forget to use Eludril
If you forget to use a dose, use it as soon as you remember unless it is time for your next dose. Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Eludril can cause side effects, although not everybody gets them.
The side-effects seen with Eludril are generally mild and disappear after stopping treatment.
If you get a rash, swelling of the mouth or face, have difficulty in breathing stop using Eludril and seek immediate medical help. These effects may be symptoms of a severe allergic reaction which is very rare.
If you get swelling or soreness of the inside of the cheeks and irritation of the mouth. Stop using Eludril and tell your doctor, dentist or pharmacist. These effects should disappear after stopping treatment.
Other side effects:
• Peeling of the skin inside the mouth. If this happens you should seek medical advice.
• Change in taste or burning sensation when you first use Eludril. This usually goes away with continued use.
• Temporary numbness of the tongue. This disappears after stopping treatment see section 2, Take special care with Eludril.
• Temporary staining of the tongue. This disappears after stopping treatment.
• Temporary staining of the teeth and dentures. You can help avoid staining
- by not drinking tea, coffee and red wine, especially one hour after using Eludril,
- by brushing your teeth and rinsing thoroughly with water and leaving a short time before using Eludril.
- Where normal brushing is not possible, or if any staining remains, your teeth may need scaling and polishing by your dentist after you have stopped treatment.
Choking. This is related to tetracaine (a mild anaesthetic) which could induce choking. This should disappear after stopping treatment.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Eludril
Keep out of the reach and sight of children.
Do not use Eludril after the expiry date which is stamped on the bottle and the label of the bottle. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep away from light.
The container of this product being pressurised, do not bum or expose it to heat, even when empty.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
15/06/10 10:49:31